Agency classClass IOur severity:Severe FDA (Devices)·Z-1855-2013·Announced 2013-08-14

Hospira Recalls Blood Sets Due to Potential Bag Puncture Risk

Hospira is recalling specific blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag."

Plain-English summary

Hospira Inc. is recalling 288 units of List No. 14211-28 PLUM BLOOD SETS. These medical devices are designed for blood product administration and feature a pre-pierced port, 200 micron filter, and non-DEHP material. The affected lots are 052945H and 211855H.

The recall was initiated because it was discovered that the piercing pin on these specific blood sets has the potential to puncture the outer wall of blood bags during the insertion of the pin. This defect could compromise the integrity of the blood product container.

The affected products were distributed nationwide in the United States, in Puerto Rico, and internationally to Costa Rica. Consumers and healthcare facilities should check their inventory for the specific list number and lot numbers listed above and stop using these products if they match the recall criteria.

The recalled product

Product: List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood…
Manufacturer: Hospira Inc.
Category: Medical Device — Blood Administration Sets
Hazard: puncture
product-integrity
Affected units: 288

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

List Number: 14211-28
Lot Numbers: 052945H
211855H

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 9 recalled by Hospira Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Same manufacturer · Hospira Inc.

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Same hazard · puncture